A Phase II Uncontrolled Study of BAY73-4506 in Previously Untreated Patients With Metastatic or Unresectable RCC

Inclusion Criteria:

Male or female patients >/= 18 years of age.
Patients, who suffer from unresectable and/or metastatic, measurable predominantly clear cell RCC (renal cell carcinoma histologically) or cytologically documented.
Patients must be previously untreated for advanced disease. Prior palliative radiation therapy is allowed if the target lesion(s) are not included within the radiation field and no more than 30% of the bone marrow is irradiated.
Patients who have at least one uni-dimensional measurable lesion by computed tomography (CT-scan) or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST).
Patients with "Intermediate" or "Low" risk per the Motzer score.
Patients who have an Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1.
Adequate bone marrow, renal and hepatic function as assessed by the following laboratory requirements to be conducted within 7 days prior to study drug treatment

Exclusion Criteria:

Patients who have received prior systemic treatment regimens for RCC.
Uncontrolled/unstable cardiac disease
Uncontrolled hypertension
Active clinically serious infections (> Common Terminology Criteria for Adverse Events [CTCAE] grade 2 )
History of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C.
Known history or symptomatic metastatic brain or meningeal tumours
Patients with seizure disorder requiring medication
Patients with evidence or history of bleeding diathesis. Any hemorrhage or bleeding event >/= CTCAE Grade 3 within 4 weeks of first dose of study.
Pregnant or breast-feeding patients